ReCharge Clinical Trial

Obesity Clinical Trial

— ReCharge  

Official title:

ReCharge Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01327976
• Other study ID #: D01088
• Status: Active, not recruiting
• Phase: Phase 3
• First received: March 31, 2011
• Last updated: April 12, 2012
• Start date: May 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2012
• Source: EnteroMedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the safety and efficacy of the Maestro RC2 System in producing weight loss in obese subjects.

Description:

The Maestro RC2 System is a neuromodulation system.

All subjects will be randomized in a 2:1 allocation to treatment or control group.

All subjects will be followed through the 12-month follow-up visit. Subjects in the control group who choose to have an active device will undergo a second surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 234
• Est. completion date: December 2016
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Informed consent.

• Body mass index (BMI) = 40 kg/m2 to 45 kg/m2 or BMI = 35 kg/m2 to 39.9 kg/m2 with one or more severe obesity related co-morbid condition.

• Females or males.

• 18-65 years of age inclusive.

• Type 2 diabetes mellitus subjects that are well-controlled.

• Failure to respond to supervised diet/exercise program(s) in which the subject was engaged within the last 5 yrs.

• Ability to complete all study visits and procedures.

Exclusion Criteria:

• Concurrent chronic pancreatic disease.

• History of Crohn's disease and/or ulcerative colitis.

• History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery.

• History of pulmonary embolism or blood coagulation disorders.

• Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant.

• Current portal hypertension and/or esophageal varices.

• Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery.

• Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial.

• Smoking cessation within the prior six months.

• Known genetic cause of obesity.

• Overall sustained reduction of more than 10% of body weight in the previous 12 months.

• Pre-operative diet with intent to lose weight prior to surgery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Device:
• Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System)
Active device will deliver VBLOC Therapy
• Active, implantable, intra abdominal vagal blocking medical device (Maestro RC2 System)
Control device will deliver no VBLOC Therapy

Locations

Country	Name	City	State
Australia	Institute of Weight Control	Baulkham Hills	New South Wales
Australia	Adelaide Bariatric Centre	Bedford Park, SA
United States	Tufts Medical Center	Boston	Massachusetts
United States	Scripps Clinic Nutrition & Metabolic Research Center	LaJolla	California
United States	University of Minnesota	Minneapolis	Minnesota
United States	Oregon Health & Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Scottsdale Healthcare Bariatric Center	Scottsdale	Arizona
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
EnteroMedics

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy objective	Observe a 10% greater EWL from randomization with the Maestro System after 12 months of VBLOC Therapy compared to control by BMI method.; Observe clinically meaningful responder rates in the treatment arm of 20% and 25% EWL from implant at 12 months (not statistically based).	12 months	No
Primary	Primary safety objective	To demonstrate a 12 month Serious Adverse Event rate related to device, implant/revision and therapy of less than 15%.	12 months	Yes